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NCT07348692PHASE3RecruitingAccepts Healthy Volunteers

Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age

Sanofi

Start Date

1/20/2026

Completion Date

5/29/2028

Summary

This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™). The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations. There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Aged 42 to 89 days on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history and physical examination * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable Exclusion Criteria: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy * History of microbiologically confirmed Streptococcus pneumoniae infection or disease * Any contraindication to the routine pediatric vaccine being administered in the study * History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy * Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3 * Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection. * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion * Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. * Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period * Previous vaccination against Streptococcus pneumoniae * Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus * Receipt of more than 1 dose of hepatitis B vaccine * Receipt of immune globulins, blood or blood-derived products since birth * Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Interventions

BIOLOGICAL

PCV21 vaccine

BIOLOGICAL

20vPCV licensed vaccine

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Conditions

Pneumococcal ImmunizationHealthy Volunteers

Locations

Northwest Arkansas Pediatric Clinic- Site Number : 8400039

Fayetteville, Arkansas 72703

United States

Matrix Clinical Research - Huntington Park- Site Number : 8400029

Huntington Park, California 90255

United States

Community Clinical Research- Site Number : 8400030

Los Angeles, California 90008

United States

Matrix Clinical Research - Los Angeles- Site Number : 8400028

Los Angeles, California 90057

United States

PAS Research - Tampa- Site Number : 8400034

Tampa, Florida 33613

United States

Kentucky Pediatric Research- Site Number : 8400036

Bardstown, Kentucky 40004

United States

Michigan Institute of Research- Site Number : 8400004

Allen Park, Michigan 48101

United States

Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008

Charleston, South Carolina 29407

United States

Parkside Pediatrics - Simpsonville- Site Number : 8400005

Simpsonville, South Carolina 29681

United States

Tribe Clinical Research - Spartanburg- Site Number : 8400026

Spartanburg, South Carolina 29301

United States

PAS Research - Children's Care Clinic- Site Number : 8400035

Edinburg, Texas 78539

United States

Pediatric Center - Richmond- Site Number : 8400038

Richmond, Texas 77469

United States

Rio Clinical Trials - Canyon View- Site Number : 8400031

Ogden, Utah 84404

United States

Investigational Site Number : 3400001

San Pedro Sula, 21104

Honduras

Investigational Site Number : 3400002

Tegucigalpa, 11101

Honduras

Investigational Site Number : 3400003

Tegucigalpa, 11101

Honduras

Investigational Site Number : 6300005

Guayama, 00786

Puerto Rico

Investigational Site Number : 6300006

San Juan, 00918

Puerto Rico

Investigational Site Number : 6300007

Trujillo Alto, 00976

Puerto Rico